Home NDC 83698-581 Menthol Flavor Cough Drop
Product NDC 83698-581
11-digit product format 836980581
Labeler code 83698
Product ID 83698-581_4718e578-22ea-6f9a-e063-6294a90a16b2
Type HUMAN OTC DRUG
Nonproprietary name Menthol Flavor Cough Drop
Dosage form LOZENGE
Route ORAL
Labeler Xiamen Kang Zhongyuan Biotechnology Co., Ltd.
Application M012
Marketing category OTC MONOGRAPH DRUG
Marketing start 2024-08-22
Substance MENTHOL
Active strength 5.4 mg/1
NDC exclude flag No
Listing certified through 2026-12-31
Current FDA listing Yes Reported adverse events (FAERS/openFDA)# Adverse event summaries are temporarily unavailable. Other product information remains available.
Additional Listing Data#
Finished product Yes
Brand name base Menthol Flavor Cough Drop
Listing expiration 2026-12-31 Active Ingredients# Ingredient, Strength table Ingredient Strength MENTHOL 5.4 mg/1
Harmonized UNII identifiers# UNII identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination L7T10EIP3A Internal UNII lookup
Harmonized RxCUI identifiers# RxCUI identifiers page 1 of 1 · 1 matching rows.
Identifier, FDA.report destination table Identifier FDA.report destination 485287 Internal RxNorm lookup
Harmonized SPL set identifiers# SPL set identifiers page 1 of 1 · 1 matching rows.
DailyMed Product Concepts# DailyMed Package Descriptions# Package NDC, Product, Description table Package NDC Product Description Form Quantity Strength SPL version 83698-581-30 Menthol Flavor Cough Drop 30 in 1 BAG LOZENGE 30 2
DailyMed Dashboard NDC Coverage# NDC, Dashboard title, SPL version table NDC Dashboard title SPL version Validation Dashboard ZIP 83698-581 MENTHOL FLAVOR COUGH DROP LOZENGE [XIAMEN KANG ZHONGYUAN BIOTECHNOLOGY CO., LTD.] 1 Current NDC, 1 package rows 20241121_274a5551-4989-d8fe-e063-6394a90aeabf.zip
openFDA label cross-check# OpenFDA label data provides additional search and identifier links. DailyMed’s Structured Product Label is the canonical label on FDA.report. Matching records are deduplicated before they are shown below.
Matched openFDA labels page 99 of 180 · 3,583 matching rows.
DailyMed RxNorm Mappings# Packages# Package NDC, 11-digit format, Description table Package NDC 11-digit format Description Units Marketing start Sample Exclude flag Status 83698-581-30 83698058130 30 LOZENGE in 1 BAG (83698-581-30) 30 lozenge 2024-08-22 No No Current